MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: November 2018

Boiron is the world’s largest manufacturer of homeopathic products. The 2016 sales figures of the company amounted to 614 489 000 Euro. Boiron has recently been very active promoting its products, not least on Twitter where I note about 10 of their promotional tweets every day. I saw the following tweet yesterday:

Acidil temporarily relieves occasional heartburn, acid indigestion, bloating or upset stomach. (link: http://bit.ly/2gCARdu)

This prompted me to look up what this product contains. The ingredients (potencies) are as follows:

  • Abies nigra (4C)
  • Carbo vegetablilis (4C)
  • Nux vomica (4C)
  • Robinia pseudoacacia (4C)

Just to remind you, 4C means the substance is diluted at a rate of 1: 100 000 000. Even the most deadly poison would be ineffective at such a dilution.

So, how can they claim that it is effective?

To find the answer, I did a Medline search and found the only listed trial of Acidil (if anyone knows of further studies, please let me know). Here is its abstract:

BACKGROUND:

It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.

METHODS:

24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.

RESULTS:

There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.

CONCLUSION:

An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.

The question I have is simple: why are they allowed to make false medical claims?

Is there anyone out there who can answer it?

This is an unusual post: it is by an osteopath who sent it to me for publication but insists he does not want to be named because he is still working in the profession. I think he has an interesting story to tell and therefore agreed to publishing his article, even though its author has to remain anonymous.

I graduated with an honours degree in osteopathic medicine in 2000 and remain registered as an osteopath. I am writing to help others avoid the same errant thought patterns that I developed, when assessing osteopathy.

My venture into the world of osteopathy began, as I am aware many have, with the assurance that osteopathy is far better than physiotherapy. There is an established musculoskeletal pathway in this country provided by physiotherapists and to wish to practice a therapy other than this, one must be sure that it is superior to physiotherapy in many aspects: effectiveness, remuneration, job satisfaction etc. And this belief was drummed into me ad nauseam by virtually all the osteopaths that I encountered. Despite hearing this for over 20 years, I have yet to see any evidence that it is the case.

The manipulative therapy at the heart of osteopathy should be a focus of strong suspicion. It is obvious that the cracks and pops elicited from spinal and peripheral joints are nothing more than a placebo party-trick, but it is a key feature of the treatment taught and practised by osteopaths throughout the country. In fact, the evidence appears to contradict the structural/mechanical model that underlies osteopathy. Spinal alignment, muscular and postural imbalances are seemingly not predisposing or maintaining factors for many musculoskeletal conditions, despite what continues to be taught in osteopathic colleges. It is hugely underappreciated that most of the factors deemed by osteopaths to be significant to a patient’s symptoms are prevalent in asymptomatic people.

The reality facing osteopaths is that spinal and musculoskeletal pain in general is so little understood, that you can only be confident in your ability to ‘treat’ it with osteopathic manipulative therapy by ignoring the complexity and opacity of the problem. Chronic low back pain for example, is such an obscure entity that it seems the success of one practitioner over another has little or nothing to do with their technical knowledge or ability, and more, maybe, to do with interpersonal dynamics. This makes for a frustrating and somewhat embarrassing career, given that the technical side of much of the work is a charade. I saw no objective reason to believe that I could do significantly more good for a patient than could be done with some basic exercise and possibly a massage.

When I graduated, there was widespread debate over whether dysfunction of the lumbo-sacral joints or the sacro-iliac joints was the most significant factor in back pain. Some osteopaths focused on one area, others on the other. I didn’t however perceive a difference in results from either group of practitioners, or from me, when switching between the two models. In fact, if I made no attempt to differentiate between the two, still no change. This proved true across the board – little or no change in outcome from a wide variety of approaches to the same issue. This is the nature of osteopathy; it is mostly vacuous as a form of assessment and treatment.

A common remark amongst osteopaths is that if you see ten osteopaths, you will get ten different diagnoses. This has consistently been my experience with my own symptoms, those of friends and family, and clinical observation. Good luck developing your ‘skill’ in that environment. Inter-practitioner repeatability was virtually non-existent when assessing the position and function of most joints of the body, especially the spine. If it is not repeatable (and very little in osteopathy is), then it is not science.

Confirmation bias was a huge factor in my education. ‘Successes’ were celebrated and failures ignored. We enjoyed reports from patients of how much good we had done but had practically no training in how osteopathy relates to scientific evidence. We still don’t have a decent body of research as to how it fares as a therapy compared to other approaches, or how specifically osteopathic treatment outcomes differ from the natural progression of symptoms.

 

Osteopathy is so far removed from mainstream medicine that it has been possible to build and maintain it on a foundation of anecdotal evidence; born of a vague perception that it must be superior to large institutionalised medicine, which is inherently inept and corrupt. There is an awareness amongst osteopaths that the evidence for osteopathy is pretty much all anecdotal but there is a faith that it will be proven effective once tested properly. Never mind the fact that anecdotal evidence is the worst form of evidence and you should not follow a system of healthcare produced by it. It is worse than no evidence, because when heeded it can lead to believing falsehoods that seem true.  In osteopathy, the scientific method has largely been ignored for groupthink and indoctrination.

Osteopaths in private practice (which is most of them) encounter huge financial pressure to over-diagnose and over-treat. Most episodes of musculoskeletal pain should be viewed as a normal part of life. They are self-limiting and do not require any formal intervention. Unfortunately, people’s anxieties are perpetuated by osteopaths who pander to the worried-well, to maintain the core of their income. Best practice for the majority of people seeking help from an osteopath is reassurance and advice to stay positive and active. This doesn’t pay well, so instead patients are given a course of manual therapy and extended ‘maintenance sessions’, both of which are of little to no short-term benefit and absolutely no long-term benefit.

But we all know that osteopaths earn more than physiotherapists right? Again, no clear data. In my experience of working in private multi-disciplinary practices, the flow of work heading the way of physiotherapists is far more consistent, given the long-established referral pathways from within the NHS and private medical insurance. Also, the NHS provides solid financial benefits and security that are not available in the parochial, private environments that osteopaths have to work in. Public and student perception of the likely earnings of an osteopath is remarkably high but there is a large swathe of osteopaths that never make a decent living from it. It is tragic to see otherwise intelligent people plough their money, time and effort into an alternative medicine cult. The same time and money could be spent pursuing a career that offers a net benefit to society and provides significant opportunity for personal development and progress, intellectually and financially.

The exultation of historical leading figures, derision of those questioning the status quo, veneration of tutors, delusions of grandeur and unshakable faith in the veracity of osteopathy are difficult influences to identify and navigate as a young student. Undergraduates need to be taught to think critically, both scientifically and philosophically. And this is especially crucial in the quagmire of alternative medicine; as the world is awash with misinformation about health. We should engender a clarity of thought, appropriate scepticism and strength of character that enables people to call bullshit sooner rather than later, in the face of such patent nonsense.

Numerous times I have been assured that osteopaths receive a similar level of education to doctors (albeit for a shorter duration), however, the serious academic training that occurs in actual medical schools makes this claim risible. Osteopaths mostly seem to think far too highly of their training; which is, in fact, fairly rudimentary. (Speaking as someone who has recently observed for a number of days in a leading teaching clinic in the UK.)

If you wish to study a musculoskeletal therapy, please, for the sake of your mental health, your financial income, your family and the good of the public; study physiotherapy. There is value in helping people deal with physical pain, the use of therapeutic exercise, and certain forms of manual therapy. Osteopathy, however, has nothing uniquely effective to offer and forms one of the most over-rated careers imaginable.

Acupuncture is a branch of alternative medicine where pseudo-science abounds. Here is yet another example of this deplorable phenomenon.

This study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.

Sixty females aged 17-23 years were randomly assigned to either a study group or a control group.

  • The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days.
  • The control group did not receive acupuncture for the same period.

Both groups were assessed on day 1; day 30 and day 60; and day 90. The results showed a significant reduction in all the variables such as the visual analogue scale score for pain, menstrual cramps, headache, dizziness, diarrhoea, faint, mood changes, tiredness, nausea, and vomiting in the study group compared with those in the control group.

The authors concluded that acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.

These findings contradict those of a recent Cochrane review (authored by known acupuncture-proponents) which included 42 RCTs and concluded that there is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.

The question that I ask myself is this: why do researchers bother to conduct studies that contribute NOTHING to our knowledge and progress? The new study had a no-treatment control group which means it cannot control for the effects of placebo, the extra attention, social desirability etc. In view of the fact that already 42 poor quality trials exist, it is not just useless to add a 43rd but, in my view, it is scandalous! A 43rd useless trial:

  • tells us nothing of value;
  • misleads the public;
  • pollutes the medical literature;
  • is a waste of resources;
  • undermines the trust in clinical research;
  • is deeply unethical.

It is high time to stop such redundant, foolish, wasteful and unethical pseudo-science.

 

I regularly scan the new publications in alternative medicine hoping that I find some good quality research. And sometimes I do! In such happy moments, I write a post and make sure that I stress the high standard of a paper.

Sadly, such events are rare. Usually, my searches locate a multitude of deplorably poor papers. Most of the time, I ignore them. Sometime, I do write about exemplarily bad science, and often I report about articles that are not just bad but dangerous as well. The following paper falls into this category, I fear.

The aim of this systematic review was to assess the efficacy and safety of herbal medicines for the induction of labor (IOL). The researchers considered experimental and non-experimental studies that compared relevant pregnancy outcomes between users and non-user of herbal medicines for IOL.

A total of 1421 papers were identified and 10 studies, including 5 RCTs met the authors’ inclusion criteria. Papers not published in English were not considered. Three trials were conducted in Iran, two in the USA and one each in South Africa, Israel, Thailand, Australia and Italy.

The quality of the included trial, even of the 5 RCTs, was poor. The results suggest, according to the authors of this paper, that users of herbal medicine – raspberry leaf and castor oil – for IOL were significantly more likely to give birth within 24 hours than non-users. No significant difference in the incidence of caesarean section, assisted vaginal delivery, haemorrhage, meconium-stained liquor and admission to nursery was found between users and non-users of herbal medicines for IOL.

The authors concluded that the findings suggest that herbal medicines for IOL are effective, but there is inconclusive evidence of safety due to lack of good quality data. Thus, the use of herbal medicines for IOL should be avoided until safety issues are clarified. More studies are recommended to establish the safety of herbal medicines.

As I stated above, I am not convinced that this review is any good. It included all sorts of study designs and dismissed papers that were not in English. Surely this approach can only generate a distorted or partial picture. The risks of herbal remedies for mother and baby are not well investigated. In view of the fact that even the 5 RCTs were of poor quality, the first sentence of this conclusion seems most inappropriate.

On the basis of the evidence presented, I feel compelled to urge pregnant women NOT to consent to accept herbal remedies for IOL.

And on the basis of the fact that far too many papers on alternative medicine that emerge every day are not just poor quality but also dangerously mislead the public, I urge publishers, editors, peer-reviewers and researchers to pause and remember that they all have a responsibility. This nonsense has been going on for long enough; it is high time to stop it.

The ‘CANADIAN COLLEGE OF HOMEOPATHIC MEDICINE’ has posted an interesting announcement:

Homeopathic Treatment of Asthma with Homeopath Kim Elia www.wholehealthnow.com/bios/kim-elia

In asthma, bronchial narrowing results in coughing, wheezing, shortness of breath, and a sense of tightness in the chest. Traditional treatments, such as bronchodilator and steroidal inhalers, reasonably control the condition, but cure is elusive. Side effects and long-term use can eventually be quite damaging, including impairment of immune function and growth rate in children. Homeopathy has an excellent track record in treating this debilitating illness, and offers the hope of weaning off of traditional injurious treatments, replacing them with a far gentler and deeper-acting solution.

About Kim Elia

Students from around the world have expressed appreciation and admiration for Kim’s superb knowledge of the history of homeopathy, his deep understanding of homeopathic prescribing, and his extensive knowledge of materia medica. He is known for his dynamic and distinctive teaching methods which reflect his immense knowledge of the remedies and his genuine desire to educate everyone about this affordable and effective healing modality.

END OF QUOTE

There a few facts that the college seems to have forgotten to mention or even deliberately distorted:

  1. Asthma is a potentially lethal disease; each year, hundreds of patients die during acute asthma attacks.
  2. The condition can be controlled with conventional treatments.
  3. The best evidence fails to show that homeopathy is an effective treatment of asthma.
  4. Therefore, encouraging homeopathy as an alternative for asthma, risks the unnecessary, premature death of many patients.

And who is Kim Elia?

Here is some background (from his own website):

  • Apparently, he was inspired to study homeopathy when he read Gandhi’s quote about homeopathy, “Homeopathy cures a greater percentage of cases than any other method of treatment. Homeopathy is the latest and refined method of treating patients economically and non-violently.” He has been studying homeopathy since 1987 and graduated from the New England School of Homeopathy.
  • Kim is the former Director of Nutrition at Heartwood Institute, California.
  • He was the Director of Fasting at Heartwood.
  • Kim was a trainer at a company providing whole food nutritional supplements.
  • Kim serves as CEO of WholeHealthNow, the distributors of OPUS Homeopathic Software and Books in North America.
  • Kim provides and coordinates software training and support, and oversees new software development with an international team of homeopaths and software developers.
  • He was inspired to create the Historic Homeopathic Timeline, and is responsible for a growing library of recorded interviews and presentations with today’s world renowned homeopaths.
  • Kim was the principal instructor and developer of the four year classical homeopathy program at the Hahnemann Academy in Tokyo and Osaka, Japan.
  • He is currently developing new homeopathy projects.

What the site does not reveal is his expertise in treating asthma.

The Canadian College of Homeopathic Medicine claims to be dedicated to the training of homeopaths according to the highest standard of homeopathic education, emphasizing the art and practice of homeopathy as outlined in Hahnemanns’s Organon of the Medical Art. We aim to further the field of homeopathy as a whole through the provision of quality, primary homeopathic care.

If that is what the highest standard of homeopathic education looks like, I would prefer an uneducated homeopath any time!

On this blog, I have repeatedly discussed chiropractic research that, on closer examination, turns out to be some deplorable caricature of science. Today, I have another example of what I would call pseudo-research.

This RCT compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).

Eligible participants were aged 65 and older with back and neck disability for more than 12 weeks. Co-primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed-model analysis to detect between group differences. Secondary analyses included other self-reported outcomes, adverse events and objective functional measures.

A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back and neck disability after 36 weeks, with no difference between groups. The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.

The authors concluded that for older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

What renders this paper particularly fascinating is the fact that its authors include some of the foremost researchers in (and most prominent proponents of) chiropractic today. I therefore find it interesting to critically consider the hypothesis on which this seemingly rigorous study is based.

As far as I can see, it essentially is this:

36 weeks of chiropractic therapy plus exercise leads to better results than 12 weeks of the same treatment.

I find this a most remarkable hypothesis.

Imagine any other form of treatment that is, like SMT, not solidly based on evidence of efficacy. Let’s use a new drug as an example, more precisely a drug for which there is no solid evidence for efficacy or safety. Now let’s assume that the company marketing this drug publishes a trial based on the hypothesis that:

36 weeks of therapy with the new drug plus exercise leads to better results than 12 weeks of the same treatment.

Now let’s assume the authors affiliated with the drug manufacturer concluded from their findings that for patients with chronic back and neck disability, extending drug therapy plus exercise from 12 to 36 weeks did not result in any additional important reduction in disability.

WHAT DO YOU THINK SUCH A TRIAL CAN TELL US?

My answer is ‘next to nothing’.

I think, it merely tells us that

  1. daft hypotheses lead to daft research,
  2. even ‘top’ chiropractors have problems with critical thinking,
  3. SMT might not be the solution to neck and back related disability.

I REST MY CASE.

 

According to the 2014 European Social Survey, Spain is relatively modest when it comes to using alternative therapies. While countries such as Austria, Denmark, Estonia, Finland, France, Germany, Lithuania, Sweden and Switzerland all have 1-year prevalence figures of over 30%, Spain only boasts a meagre 17%. Yet, its opposition to bogus treatments has recently become acute.

In 2016, it was reported that a master’s degree in homeopathic medicine at one of Spain’s top universities has been scrapped. Remarkably, the reason was “lack of scientific basis”. A university spokesman confirmed the course was being discontinued and gave three main reasons: “Firstly, the university’s Faculty of Medicine recommended scrapping the master’s because of the doubt that exists in the scientific community. Secondly, a lot of people within the university – professors and students across different faculties – had shown their opposition to the course. Thirdly, the postgraduate degree in homeopathic medicine is no longer approved by Spain’s Health Ministry.”

A few weeks ago, I had the great pleasure of being invited to a science festival in Bilbao and was impressed by the buoyant sceptic movement in Spain. At the time, two of my books were published in Spanish and received keen interest by the Spanish press.

 

And now, it has been reported that Spain’s Ministry of Health has released a list of only 2,008 homeopathic products whose manufacturers will have to apply for an official government license for if they wish to continue selling them. The homeopathic producers have until April 2019 to prove that their remedies actually work, which may very well completely slash homeopathic products in Spain.

It’s the latest blow for Spain’s homeopathy industry, once worth an estimated €100 million but which has seen a drop in public trust and therefore sales of around 30 percent in the last five years. Spain’s Health Ministry stopped allowing homeopathy treatments from being prescribed as part of people’s social security benefits, along with acupuncture, herbal medicine and body-based practices such as osteopathy, shiatsu or aromatherapy.

“Homeopathy is an alternative therapy that has not shown any scientific evidence that it works” Spanish Minister of Health Maria Luisa Carcedo is quoted as saying in La Vanguardia in response to the homeopathic blacklist. “I’m committed to combatting all forms of pseudoscience.”

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